Z-2415-2011

Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07...

Name: Z-2415-2011 Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07...
Creator: Terumo Medical Corporation
Published: 2010-06-24
License: https://open.fda.gov/license/

Terumo Medical Corp. / initiated 2010-06-24 / Terminated / root cause: manufacturing process

FDA source

Terumo Medical Corporation began a recall of Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to... on 2010-06-24. The reason FDA records is "Molding defect in destination product that render the device unusable". 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-2415-2011
Status: Terminated
Initiated: 2010-06-24
Posted: 2011-06-06
Terminated: 2011-07-07
Recalling firm: Terumo Medical Corp.
Product: Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.
Product code: DYB Introducer, Catheter
Reason for recall: Molding defect in destination product that render the device unusable.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Terumo Medical Corporation sent an Urgent Product Bulletin Recall letter dated June 24, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo requested customers to immediately discontinue use, and quarantine any available stock of the listed product codes. In order to facilitate the exchange of these devices, a Terumo Territory Manager contacted all customers by July 9th to confirm receipt of the Terumo Destination Bulletin and scheduled an appointment to visit each customer in person by July 31st to personally manage the exchange. For questions or for further information, call (800) 283-7866 and ask to speak with the Product Recall Coordinator.
Quantity in commerce: 214 units
Distribution: Worldwide Distribution - USA including AL, AK, AZ, TX, LA, MS, MN, MO, CA, GA, FL, HI, KS, IA, ID, IL, TN, NM, OR, OK, WA, and WI and the countries of Belgium, Brazil, and Panama
Product codes and lots: RSC01

Product code DYB

K012812Class IICarotid Guiding SheathTerumo Medical Corp. / cleared 2001-11-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)