The Recall Desk
HighFDA (Devices)·Z-0347-2025·Announced 2024-11-20

Approach Hydro ST Micro Wire Guide Recalled for Incorrect Expiration Dates

Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices because affected device labels contain incorrect expiration dates. Using mislabeled devices beyond their actual expiration creates a risk of device failure and patient harm.

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: FDA Class II recall for labeling error with incorrect expiration dates on medical devices. No illnesses or injuries are reported, but mislabeling creates a risk of harm if devices are used beyond their actual expiration. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Cook Incorporated is recalling Approach Hydro ST Micro Wire Guide devices (reference part numbers HMW-14-135-ST, HMW-14-190-ST, and HMW-14-300-ST). Approximately 5,953 units were distributed in the US and 2,528 units distributed internationally.

The recall was issued because labels on affected device lots contain incorrect expiration dates. Devices labeled with incorrect expiration dates may be used after their actual expiration, creating a risk that the device will not function as intended and potentially compromising patient safety.

Affected lot numbers are identified by UDI-DI and lot codes and can be verified on the FDA website. Healthcare providers and patients with affected devices should check their device lot numbers and expiration dates immediately.

Those in possession of affected devices should contact Cook Incorporated for guidance on device replacement and proper handling.

The recalled product

Product
Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST
Manufacturer
Cook Incorporated
Category
Medical Device — Guidewire
Hazard
  • labeling-error
  • expired-device-risk

Distribution

Distributed nationwide across the United States.

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