Greatbatch Medical Recalls MobiCath Bi-Directional Guiding Sheaths Due to Liner Anomalies
Greatbatch Medical is recalling MobiCath Bi-Directional Guiding Sheaths because visual inspections found loose or frayed liner material inside the device.
What this means for you
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 physical defects (liner anomalies) that pose a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Greatbatch Medical is recalling 10,201 units of the Biosense Webster MobiCath Bi-Directional Guiding Sheath, including Small Curve (catalog no. D140010) and Large Curve (catalog no. D140011) models. The recall covers specific lot numbers listed in the agency documentation.
The recall was initiated after Greatbatch Medical observed anomalies in the inner lumen of the sheaths following the implementation of a new visual inspection tool. These anomalies include loose, string-like liner material, liner abrasion or fraying, and attached string-like material resulting from scratches or damage on the inner wall of the sheath lumen.
The affected devices were distributed worldwide, including in the United States and various countries in Europe, Australia, and Canada. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer designed for gaining access to the coronary systems and introducing cardiovascular catheters into the heart.
The recalled product
- Product
- 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 (or guiding sheath) designed for gaining access to the cor
- Manufacturer
- Greatbatch Medical
- Affected units
- 10,201
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 (20)
- LOT: R1701247
- R1713591
- W2046680
- W2046681
- W2072907
- W2078460
- W2084872
- W2098771
- W2102124
- W2102133
- W2102134
- W2108295
- W2108296
- W2108298
- W2108299
- W2125688
- W2125690
- W2132584
- W2132588
- W2132590
Distribution
Related recalls
Same manufacturer · Greatbatch Medical
See all →- HighGreatbatch Recalls ViaPeel Introducer Sheaths Due to Handle Detachment
FDA (Devices) · 2017-08-09
- 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
- HighGreatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
FDA (Devices) · 2016-12-07
Same hazard · device defect
See all →- HighBoston Scientific ENROUTE Transcarotid Neuroprotection System Recall for Tip Separation
FDA (Devices) · 2026-08-26
- HighMicrovention Recalls Bobby Balloon Guide Catheters Due to Pinhole Defects
FDA (Devices) · 2026-08-19
- SevereMedtronic Perfusion Systems Recalls EOPA Elongated One-Piece Arterial Cannula Model 77722
FDA (Devices) · 2026-08-05
- SevereABIOMED Impella CP Introducer Kit 14 Fr potentially defective sheath
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Smart Assist Set Heart Pump Introducer Sheath Leakage
FDA (Devices) · 2026-07-22