The Recall Desk
SevereFDA (Devices)·Z-0798-2016·Announced 2016-03-02

Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Splits

Cook Inc. is recalling 9,519 Shuttle Select Slip-Cath Catheters worldwide due to reports of catheter tip splits and separation, which can cause loss of function or complications.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states that complications resulting from separated tips occluding blood flow to end organs may result, which aligns with the rubric criterion for 'significant injury/property-damage reports' or risk of serious harm.

Plain-English summary

Cook Inc. is recalling 9,519 units of the Shuttle Select Slip-Cath Catheter, an angiographic catheter used in medical procedures to deliver contrast media and help diagnose occlusion or stenosis. The recall covers specific product numbers including SCBR4.5-35-35-135-P-NS-ANG-SHTL and related variants.

The recall was initiated due to reports of catheter tip splits and separation. These defects can lead to a loss of device function, require medical intervention to retrieve the separated segment, or cause complications if the separated tip occludes blood flow to end organs. The recall was expanded on October 7, 2015, to include additional catheters.

The affected devices were distributed worldwide, including in the United States (nationwide including Puerto Rico and US Virgin Islands) and numerous international locations. Consumers and healthcare providers should stop using the affected catheters and contact Cook Inc. for further instructions.

The recalled product

Product
Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular syst
Manufacturer
Cook Inc.
Affected units
9,519

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 (4)

  • SCBR4.5-35-135-P-NS-ANG-SHTL-JP
  • SCBR4.5-35-150-P-NS-0-SHTL
  • SCBR4.5-35-150-P-NS-ANG-SHTL
  • SCBR4.5-35-75-P-NS-ANGSHTL

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: