Medtronic Inc. Cardiac Rhythm Disease Management: Medical Device Recall in 2015 - (Recall #: Z-1276-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.

Product Classification:

Class I

Date Initiated: February 23, 2015

Date Posted: March 25, 2015

Recall Number: Z-1276-2015

Event ID: 70644

Reason for Recall:

Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.

Status: Terminated

Product Quantity: 151 (4 US, 147 OUS)

Code Information:

Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.

Distribution Pattern:

Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.

Voluntary or Mandated:

Voluntary: Firm initiated