Boston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
Boston Scientific is recalling 403 units of NaviFlex LW Pusher and Advx Panc. Stent devices due to an incorrect manufacturing feature.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as Class II because the devices were manufactured with an incorrect design feature, a guidewire exit port, which is not associated with this configuration. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Boston Scientific Corporation is recalling 403 units of the NaviFlex LW Pusher and Advx Panc. Stent 4/5F. The recall involves specific material numbers and lot numbers, including M00535030, 38904309, 39017263, and 39365322. The devices were distributed nationwide in the United States to states including Alabama, California, Florida, Georgia, Illinois, Indiana, Kentucky, Maryland, North Carolina, New Hampshire, New Mexico, New York, Rhode Island, Texas, Washington, Wisconsin, and West Virginia.
The recall was initiated because the devices were incorrectly manufactured with a guidewire exit port, referred to as the RX port in the instructions for use. This port is not a design feature associated with this specific device configuration. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices.
Healthcare providers and facilities that have received these devices should stop using them and contact Boston Scientific Corporation for further instructions on the recall process.
The recalled product
- Product
- NaviFlex LW Pusher; Advx Panc. Stent 4/5F; Material Number (UPN): M00535030;
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 403
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 (5)
- Material Number (UPN): M00535030
- UDI-DI: 08714729856191
- Lot Number: 38904309
- 39017263
- 39365322
Distribution
Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
Same hazard · manufacturing defect
See all →- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07