MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #'s: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Oscor, Inc.
- Reason for Recall:
- Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Product Codes/Lot Numbers:
Lot #'s: C1-08273 Exp. October 8, 2016, C1-08340 Exp. November 11, 2016, C1-08605 Exp. February 20, 2017, C1-08608 Exp. February 20, 2017, C1-08816 Exp. April 8, 2017, C1-08940 Exp. May 19, 2017, C1-09102 Exp. July 21, 2017, C1-09169 Exp. August 21, 2017, C1-09170 Exp. August 21, 2017, C1-09361 Exp. November 3, 2017, C1-09693 Exp. February 10, 2018, C1-09742 Exp. February 16, 2018, C1-09743 Exp. February 16, 2018, C1-09862 Exp. March 5, 2018, C1-09903 Exp. March 15, 2018, C1-10041 Exp. April 5, 2018, C1-10148 Exp. April 23, 2018, C1-10185 Exp. April 27, 2018, C1-10214 Exp. April 29, 2018, C1-10324 Exp. May 11, 2018,C1-11439 Exp. September 16, 2018, C1-11440 Exp. September 16, 2018, C1-11485 Exp. September 22, 2018, C1-11623 Exp. September 29, 2018, C1-11622 Exp. September 29, 2018, C1-11852 Exp. October 16, 2018, OR-04759 Exp. December 22, 2018, and OR-04758 Exp. December 22, 2018
Distribution:
Distributed in: US, CA, NJ, MD, TX, FL, NC, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0812-2017
Related Recalls
There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.
Potential for open seal on sterile product
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.