Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect
Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.
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: This is an FDA Class II recall with no reported illnesses or injuries and a theoretical hazard (potential sterile barrier compromise). Per the rubric, recalls with no reported harm and theoretical risk are at most Score 3. The defect poses a risk-of-harm through compromised device sterility, justifying the High classification.
Plain-English summary
Boston Scientific Corporation is recalling the VTC Regular Kit Nephrostomy Catheter System Kit (Material Number REF M001245300) used for external drainage of the urinary tract.
The device pouches may contain holes in the clear sterile barrier. These holes could compromise the sterility of the catheter before clinical use.
The recalled devices were distributed in the United States, Colombia, Philippines, and Russia. The affected lot is 33751204 with an expiration date of 04/03/2027, affecting 5 units.
Healthcare providers and patients should discontinue use of affected units. Contact Boston Scientific for instructions regarding replacement or return of the product.
The recalled product
- Product
- VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 5
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 (3)
- GTIN/UDI 0871472904856
- Lot # 33751204
- exp. 04/03/2027
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- 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
Same hazard · sterile barrier defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05
Similar recalls
- HighBoston Scientific Recalls Malecot Nephrostomy Catheters Due to Breakage
FDA (Devices) · 2018-03-28
- HighBoston Scientific Recalls Re-Entry Malecot Nephrostomy Catheter Sets
FDA (Devices) · 2018-03-28
- HighBoston Scientific Recalls RunWay Guide Catheters Due to Sterility Concerns
FDA (Devices) · 2014-03-19
- HighSterile barrier breach recalled in Boston Scientific HYDRATOME RX catheters
FDA (Devices) · 2022-03-23
- HighBoston Scientific Recalls Malecot Nephrostomy Catheters Due to Mid-Shaft Breakage
FDA (Devices) · 2018-03-28
- HighBoston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error
FDA (Devices) · 2013-07-17