Data / Medical devices / United States / Greatbatch Medical
Greatbatch Medical: FDA-registered device maker in Minneapolis, MN, United States, 7 510(k) clearances and 1 PMA approval
Greatbatch Medical is registered with the FDA (registration 2183787) in Minneapolis, MN, United States. It lists 7 device types. The FDA files 7 510(k) clearances and 1 PMA approval under its listings, the newest dated July 26, 2018. 22 recall events name it as the recalling firm (2 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2183787
- Address
- 2300 Berkshire Lane North, Minneapolis, MN, United States, 55441
- Owner or operator
- GREATBATCH MEDICAL (9035261)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- July 1, 2009
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intracardiac Mapping, High-Density Array | MTD | 2 | Contract manufacturer | accessdata.fda.gov |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | 3 | Contract manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pacemaker Lead Adaptor | DTD | 2 | Manufacturer | accessdata.fda.gov |
| Permanent Defibrillator Electrodes | NVY | 3 | Contract manufacturer | accessdata.fda.gov |
| Permanent Pacemaker Electrode | DTB | 3 | Manufacturer | accessdata.fda.gov |
| Stimulator, Hypoglossal Nerve, Implanted, Apnea | MNQ | 3 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 26, 2018 | K181855 | RadialSeal Introducer Kit | DYB | Substantially Equivalent | Great Batch Medical | accessdata.fda.gov |
| November 16, 2010 | K102540 | PTFE PORTABLE INTRODUCER | DYB | Substantially Equivalent | Great Batch Medical | accessdata.fda.gov |
| March 15, 2010 | K093232 | OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER | DYB | Substantially Equivalent | Great Batch Medical | accessdata.fda.gov |
| November 9, 2007 | K072248 | VIAPEEL PEELABLE INTRODUCER | DYB | Substantially Equivalent | Enpath Medical, Inc. | accessdata.fda.gov |
| July 5, 2007 | K071574 | STIFFER COAXIAL MICRO-INTRODUCER KIT | DYB | Substantially Equivalent | Enpath Medical, Inc. | accessdata.fda.gov |
| June 28, 1999 | K990705 | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET | DYB | Substantially Equivalent | Medamicus, Inc. | accessdata.fda.gov |
| March 3, 1987 | K870562 | DAIG PACEMAKER LEAD ADAPTOR | DTD | Substantially Equivalent | Daig Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 2015 | P130012 | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD | DTB | 13 | April 19, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 23, 2017 | 77120 | Class II | Terminated | Linear Straight Broach Handle (Rasp Handle) (Greatbatch Part # 510397; DJO Surgical Inc., # 803-03-159) and EZ Clean" Linear Broach Handle Greatbatch Part # T11824, DJO Surgical Inc. # 803-03-059). | Greatbatch Medical has voluntarily initiated a Recall for the Linear Straight Broach Handle (Rasp Handle) and EZ Clean" Linear Broach Handle. Greatbatch Medical has received reports that that the product is breaking at the welds and that the locating pin at the distal end of the instrument is breaking off during use. | accessdata.fda.gov |
| February 15, 2017 | 76514 | Class II | Terminated | Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding | One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed. | accessdata.fda.gov |
| November 11, 2016 | 76701 | Class II | Terminated | ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006 | Greatbatch received complaints with the ViaPeel Introducer Sheath 5FR, of handles detaching during use. | accessdata.fda.gov |
| October 19, 2016 | 76236 | Class II | Terminated | Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed us | On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA. | accessdata.fda.gov |
| September 8, 2016 | 75145 | Class II | Terminated | Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Micro-Introducer 5FR. The radiopaque Stiffer Coaxial Micro-Introducer (Figure 1) consi | Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during use. | accessdata.fda.gov |
| August 2, 2016 | 75043 | Class I | Terminated | Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 | On December 17, 2015, Greatbatch discovered that the Standard Offset Cup Impactor with a POM-C handle grip failed sterility testing when housed in a dedicated instrument case using the sterilization parameters identified in the Standard Offset Cup Impactors Instructions for Use (IFU). | accessdata.fda.gov |
| April 26, 2016 | 73948 | Class II | Terminated | Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TL | Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device. | accessdata.fda.gov |
| April 28, 2014 | 68161 | Class II | Terminated | Coaxial Micro-Introducer Kit. Greatbatch Part Number/Bard Access Systems Order Number/Part Description 10636-001 8004011 Kit Coax 10 Pack 4FR Bard 10636-002 8005011 Kit Coax 10 Pack 5FR Bard 10636-007 8004012 Kit Coax 10 | Greatbatch identified that the documentation does not support the five-year shelf life of the Bard Access Division Coaxial Micro-Introducer Set. | accessdata.fda.gov |
| January 31, 2014 | 67392 | Class I | Terminated | Greatbatch Medical, Offset Cup Impactor. Part Numbers: P9485, T10243, T10281, T10287, T10484, T10491, T10507, T10600, T10604, T10753, T10861, T11209, T11340, T12121, T12230, T12288, T12305, T12391, T12699, T12767, T12861 | Greatbatch Medical has initiated a global Field Corrective Action for the Standard Offset Cup Impactor since the product was first released in 2004. Greatbatch has identified through internal Sterility Assurance Level validation testing that a sterility assurance level of 10-6 is not achieved on the Standard Offset Cup Impactor when it is subjected to the st | accessdata.fda.gov |
| May 31, 2013 | 65464 | Class II | Terminated | Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th | Cordis Corporation, Inc and Greatbatch Medical are recalling one lot of the cordis RADIALSOURCE Spring Wire Transradial Access Kit product. Some units were manufactured with an undersized vessel dilator tip, too small to slide over the guidewire. | accessdata.fda.gov |
| January 16, 2013 | 64129 | Class II | Terminated | 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. | Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45 product line. Greatbatch has received reports of noisy and / or rough operation when using these Small Angled Drivers. | accessdata.fda.gov |
| November 12, 2012 | 63676 | Class II | Terminated | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer | Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). | accessdata.fda.gov |
| September 24, 2012 | 63316 | Class II | Terminated | Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer | We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths. | accessdata.fda.gov |
| September 6, 2012 | 63141 | Class II | Terminated | Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire | During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient. | accessdata.fda.gov |
| July 2, 2010 | 56281 | Not yet classified | Terminated | Greatbatch OptiSeal Valved PTFE Peelable Introducer, Model 1000093-001, 1000093-002, 1000093-003, 1000093-004, 1000093-005, 1000093-006, 1000093-007. Sterilized using Ethylene Oxide. Greatbatch Medical, 2300 Berkshire La | The outer sterile barrier (pouch) packaging for the 12 Fr device is not intact. No breaches in the inner sterile barrier (tray/tyvek lid) have been identified. The OptiSeal introducer and accessories sealed in the tray are sterile. Infection may result if a sterile field is contaminated by the outer surface of the inner tray. | accessdata.fda.gov |
| May 13, 2010 | 56324 | Not yet classified | Terminated | enpath medical Myopore Sutureless Myocardial Pacing Lead, Bipolar (labeled as Unipolar) Connector,, REF 511212. 54 cm. Distributed by Guidant/CPI. Contents in unopened, undamaged package have been sterilized by ethylene | The Myopore Bipolar Epicardial Leads packaging is labeled as unipolar leads. The lead body itself is correctly labeled as bipolar. This could result in a bipolar lead being implanted with a pulse generator operating in unipolar mode. | accessdata.fda.gov |
| September 1, 2009 | 53777 | Not yet classified | Terminated | Enpath Lead Adapter, Ref: 501214. The contents of the inner package have been sterilized by ethylene-oxide gas. Enpath Medical, Inc., 2300 Berkshire Lane North, Minneapolis, MN 55441 USA. | The silicone tubing of affected leads was processed outside of validated parameters. Although the material remains biocompatible, test data regarding the performance characteristics are not available. | accessdata.fda.gov |
| July 18, 2006 | 35983 | Not yet classified | Terminated | Enpath Lead Adapters, pacemaker lead adapter. Affects: 5 mm Bipolar, Model 501205; 6 mm Unipolar, Model 501204; 3.2 mm Low-Profile Bipolar Models 501206 and 501214. All labeled Sterile, EO, mail: Enpath Medical, Inc. Lea | Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device. | accessdata.fda.gov |
| June 27, 2006 | 35827 | Not yet classified | Terminated | Channel Steerable Sheath in 8F Enpath part # 10775-003, BARD Part Number XD10775003 (US Distribution Only) and 9F Enpath part # 10775-004 (foreign distribution), BARD Part Number XD10775004; Labeled as Distributed by Bar | Enpath has become aware that some of the Enpath Medical 8F & 9F Steerable sheath devices may have a non-conforming flushport bond that causes a leak where air may enter the flush port chamber. | accessdata.fda.gov |
| August 31, 2005 | 33338 | Not yet classified | Terminated | Enpath Steerable Sheath, model 10775-003, Sterile EO. Single Use Only. Enpath Medical, Inc., 15301 Highway 55 West, Minneapolis, MN 55447, USA. The Enpath Deflectable Catheter is a felexible tipped percutaneous catheter | Enpath has become aware that some of the Enpath Medical 8 Fr Steerable sheath devices may have non-conforming hemostasis valves in that the valve can leak or the valve was observed to have a small hole. | accessdata.fda.gov |
| February 26, 2004 | 28419 | Not yet classified | Terminated | AngioDynamics Incorporated 21 Gauge Micro Access Needle, B-Bevel - 4 cm length, catalog No. 06506803 | The product is labeled as sterile product but had not been sterilized. | accessdata.fda.gov |
| June 6, 2003 | 26475 | Not yet classified | Terminated | Medamicus FlowGuard 16 FR Valved Peelable Introducer Kit, Catalog Number 10532-011 | Stability testing, after accelerated aging of the device, showed that the handle of device did not meet strength specifications. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Stimulator, Hypoglossal Nerve, Implanted, Apnea
- All makers of Permanent Pacemaker Electrode
- All makers of Pacemaker Lead Adaptor
- All makers of Catheter, Intracardiac Mapping, High-Density Array
- All makers of Implantable Cardioverter Defibrillator (Non-Crt)
Updated April 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.