Destination Guiding Sheaths (2016-05-17)

Starting date:

May 17, 2016

Posting date:

May 31, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58696

• Reason
• Affected products

Affected products

1. Destination Peripheral Guiding Sheath
2. Destination Carotid Guiding Sheath
3. Destination Renal Guiding Sheath

Reason

Certain Pinnacle Destination guiding sheaths containing an expiration date on or before August 31, 2018, may fail to meet product specifications for insertion force of 40 grams (1.4 ounces). If a guiding sheath does not have sufficient lubricity, there may be increased resistance noted during the insertion of the device into the patient, especially if the patient has scar tissue or difficult anatomy.

Affected products