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Terminated

Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.

FDA Recall Z-0908-2013 · Posted 2013-03-05

Recalling FirmMedtronic Inc. Cardiac Rhythm Disease Management
Recall StatusTerminated
Product CodeDWF
Date Initiated2013-02-19
Date Terminated2013-11-21
Product Quantity13,691 (6711 USA; 6980 OUS)

Reason for Recall

Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.

Firm Action

Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120988DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHTMedtronic, Inc. · 2012-07-25K842375VENOUS CANNULA W/BENT, TIP WIREDlp, Inc. · 1984-08-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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