Greatbatch Recalls ViaPeel Introducer Sheaths Due to Handle Detachment
Greatbatch Medical is recalling 5,000 ViaPeel PTFE Peelable Introducer 5FR devices because handles may detach during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical failure (handle detachment) that poses a risk of harm during use, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Greatbatch Medical is recalling 5,000 units of the ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006. The recall is due to reports that the handles on these devices may detach during use.
The affected devices are identified by Lot Number W3101005. The distribution pattern is listed as NY, indicating the devices were distributed in New York.
Healthcare providers and patients should stop using the affected devices and contact Greatbatch Medical for further instructions or a replacement.
The recalled product
- Product
- ViaPeel PTFE Peelable Introducer 5FR, Part Number 10890-006
- Manufacturer
- Greatbatch Medical
- Hazard
- Affected units
- 5,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: W3101005
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Greatbatch Medical
See all →- ModerateBiosense Webster MobiCath Guiding Sheath Recalled for Unsealed Pouch
FDA (Devices) · 2017-08-09
- HighGreatbatch Medical Recalls Linear Straight Broach Handles Due to Weld Breakage
FDA (Devices) · 2017-05-17
- ModerateGreatbatch Recalls T5766 Offset Reamer Handles Due to Drive Chain Seizure
FDA (Devices) · 2017-02-22
- SevereGreatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
FDA (Devices) · 2016-12-07
- HighGreatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer
FDA (Devices) · 2016-11-30
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereNavilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment
FDA (Devices) · 2017-12-20
- HighNavilyst Medical Recalls Xcela and BioFlo PICC Kits
FDA (Devices) · 2017-12-20
- HighNavilyst Medical Recalls PICC Kits Due to Potential Handle Detachment
FDA (Devices) · 2017-12-20
- SevereNavilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Handle Detachment Risk
FDA (Devices) · 2017-12-20
- HighNavilyst Medical Recalls Xcela and BioFlo PICC Kits Due to Sheath Defect
FDA (Devices) · 2017-12-20
- HighGreatbatch Stiffer Coaxial Micro-Introducer Recalled for Detaching Luer
FDA (Devices) · 2016-11-30