Z-1276-2015Class I

Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select)...

Name: Z-1276-2015 Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select)...
Creator: Medtronic Inc. Cardiac Rhythm Disease Management
Published: 2015-02-23
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-02-23 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Disease Management began a recall of Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction... on 2015-02-23. FDA classified it as Class I and gives the reason as "Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1276-2015
Classification: Class I
Status: Terminated
Initiated: 2015-02-23
Posted: 2015-03-17
Terminated: 2015-10-07
Recalling firm: Medtronic, Inc.
Product: 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 code: DYB Introducer, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: [email protected] or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization. Your Medtronic field representative may assist the customers with identifying suitable replacement product. If you have any questions, contact Customer Service at 1-800-848-9300.
Quantity in commerce: 151 (4 US, 147 OUS)
Distribution: Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
Product codes and lots: Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1276-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1276-2015	Class I	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-17

Product code DYB

K142684Class IIFlexCath Select Steerable Sheath (10 French)Medtronic Cryocath, LP / cleared 2014-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)