Z-0535-2018Class II

Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary...

Name: Z-0535-2018 Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary...
Creator: Medtronic Perfusion Systems
Published: 2018-01-03
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2018-01-03 / Terminated

FDA source

Medtronic Perfusion Systems began a recall of Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures on 2018-01-03. FDA classified it as Class II and gives the reason as "Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0535-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-03
Posted: 2018-01-30
Terminated: 2020-10-05
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB) surgical procedures.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
FDA root cause: Component change control
Action: In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.
Quantity in commerce: 2914 units
Distribution: DE, IA, CA and Japan
Product codes and lots: a) REF 2815R1, UPN/GTIN: 20885074191038, Lot/Serial Numbers: 210937492, 213151103, 213671744 b) REF 2D25R6, UPN/GTIN: 00613994268174, Lot/Serial Numbers: 209533592, 209759280, 209948919, 210174899, 210377603, 210478517, 210591995, 210767149, 211011818, 211210404, 211243436, 211542842, 211761616 c) REF 9M68R, UPN/GTIN: 20643169876648, Lot/Serial Numbers: 212067087, 212796361 d) REF BB4B15R13, UPN/GTIN: 00643169845121, Lot/Serial Numbers: 211804184, 212073924, 212266962, 212268301, 212385983, 212552883, 212796215, 213248430, 213583108 e) REF BB4B15R14, UPN/GTIN: 00763000025878, Lot/Serial Numbers: 213801240, 213868837 f) REF BB9L72R, UPN/GTIN: 00643169845077, Lot/Serial Numbers: 211715103 g) REF BB9L72R1, UPN/GTIN: 00643169872127, Lot/Serial Numbers: 212020797, 212174623, 212193001, 212301586, 212355584, 212428238, 212626142, 212884370, 213001157, 213248459, 213631247, 213672934, 213802501, 214072742, 214093025 h) REF CB1Z87R11, UPN/GTIN: 00643169741591, Lot/Serial Numbers: 211755326 i) REF CB4L56R24, UPN/GTIN: 00643169735989, Lot/Serial Numbers: 211654744, 211654745, 211800954 j) REF CB4L56R26, UPN/GTIN: 00643169906181, Lot/Serial Numbers: 212294432, 212404544, 212447345, 212489670, 213251146, 213251166, 213358174, 213573495, 213623995, 214053395 k) REF CB5S68R3, UPN/GTIN: 20613994490760, Lot/Serial Numbers: 210937507 l) REF CB7X82R4, UPN/GTIN: 00643169471986, Lot/Serial Numbers: 211050766, 211320749 m) REF CB7X82R5, UPN/GTIN: 00643169789517, Lot/Serial Numbers: 211423503, 211443209, 211443210, 211885323, 211991293, 212154744, 212235237, 212274655, 212428312, 212473311, 212671632, 212962650, 213126447, 213292357, 213377926, 213445426, 213494394, 213494396, 213672914, 213906498, 214043035, 214093030 n) REF HY6Y19R5, UPN/GTIN: 00643169510432, Lot/Serial Numbers: 210802114, 210945613, 211114272, 211210180, 211327621, 211654742, 211846417, 212235012, 212545229, 212835348 o) REF HY8M65R2, UPN/GTIN: 00643169661295, Lot/Serial Numbers: 210952226, 211335076, 211558225, 211722651, 212028419, 212222066, 212355669, 213001001, 213719738 p) REF TL8W39R6, UPN/GTIN: 00643169715097, Lot/Serial Numbers: 210731697, 210838201, 210937704

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0535-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-06

Product code DWF

K171308Class IITubing PackMedtronic, Inc. / cleared 2017-06-02

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)