The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0020-2024·Announced 2023-10-11

Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape

Boston Scientific is recalling certain lots of Guider Softip cardiac guide catheters because they were distributed with an incorrect tip curve shape that doesn't match the product label. Approximately 3,738 units were affected.

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: FDA Class II recall of a cardiac guide catheter with a confirmed manufacturing defect: certain units have an incorrect tip curve shape that differs from the labeled specification. The recall notice does not document any reported illnesses or adverse events. The combination of Class II classification, a confirmed defect in a high-risk medical device, and absence of reported adverse events warrants High severity (Score 3).

Plain-English summary

Boston Scientific Corporation is recalling certain lots of its Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, a cardiac guide catheter (catalog number M003101460). The affected units were distributed with a tip curve shape that differs from the labeled tip curve shape.

The mismatch between the physical device and its labeled specification constitutes the reported defect. A guide catheter's tip curve is essential to its design and intended function during cardiac procedures.

Approximately 3,738 units were distributed. The affected lot/batch numbers are: 26059697, 26339267, 26339269, 26590800, 26746116, 26891817, 26891818, 27065537, 27288435, 27535145, 27592321, 28132917, 28384670, 25715225, 25715226, 26059695, 26339266, 26339268, 26498391, 26590801, 26746114, 26746115, 26891816, 28632177, 27081948, 27254932, 27280217, 27435623, 27558595, 27592320, 27767765, 27824570, 28115146, 28738180, 28384671, 28632176, 28632178, 28632179, 28737899, 28738181, 28886805, 28886806, 28886807, 29113162, 28795500.

Do not use affected devices in patient procedures. Contact Boston Scientific Corporation or your device supplier for guidance on replacement or return of affected units.

The recalled product

Product
Guider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac guide catheter
Manufacturer
Boston Scientific Corporation
Category
Medical Device — Cardiac / Guide Catheter
Hazard
Affected units
3,738

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)

  • GTIN 08714729244332
  • Lot/Batch Numbers: 26059697
  • 26339267
  • 26339269
  • 26590800
  • 26746116
  • 26891817
  • 26891818
  • 27065537
  • 27288435
  • 27535145
  • 27592321
  • 28132917
  • 28384670
  • 25715225
  • 25715226
  • 26059695
  • 26339266
  • 26339268
  • 26498391

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 16 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 16 products in this recall →

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