—#157133

Product

DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

FDA product code: DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K852232
Affected lot / code info: Model No. 61000: Product UPN: 20613994846604: Lot No. 2016020865, 2016030859, 2016031538, 2016040539, 2016040859, 2016050268, 2016050556, 2016051179, 201605C063, 201605C064, 201605C065, 201605C066, 201605C067, 201605C068, 201605C069, 2016060275, 2016060525, 2016060896, 2016060897, 2016061082, 2016061083, 2016061084, 2016061476, 2016061477, 2016061478, 2016061479, 2016061480, 2016070727, 2016070744, 2016070753, 2016070962, 2016070963, 201607C046, 201607C047, 2016080349, 2016081585, 2016081586, 2016081587, 2016090237, 2016090593, 2016090594, 2016091409, 2016091410, 2016100571, 2016100572, 2016100875, 2016100876, 2016110851, 2016110852, 2016111130, 2016111131, 2016111132, 2016111133, 2016120836, 201612C037, 2017010052, 2017020120, 2017020122, 2017021065, 2017021066, 2017030114, 2017030115, 2017030116, 2017030117, 2017030118, 2017030119, 2017030595, 2017030951, 2017031135, 201703C055. Model 62000: Product UPN: 20613994846642: Lot No. 2016040236, 2016040540, 2016041196, 2016051245, 201605C015, 201605C016, 2016060226, 2016060526, 2016060899, 2016061085, 2016061086, 2016061482, 2016070542, 2016070964, 2016070965, 2016080350, 2016081588, 2016081589, 2016091146, 2016100654, 2016110453, 2016110854, 2016120837, 2017010583, 2017010945, 201701C037, 2017021067, 2017021068, 2017030596, 201703C104, 2017040147.

Why it was recalled

Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.

Root cause (FDA determination)

Packaging process control

Action the firm took

Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Service at 1-800-854-3570. For questions regarding this recall call 763-526-2494.

Recalling firm

Firm: Medtronic Perfusion Systems
Address: 7611 Northland Dr N, Brooklyn Park, Minnesota 55428-1088

Distribution

Distribution pattern: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.

Timeline

Recall initiated: 2017-06-22
Posted by FDA: 2017-07-10
Terminated: 2020-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157133. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.