DLP recallZ-2768-2017 · Medtronic Perfusion Systems · initiated Jun 22, 2017

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number: Z-2768-2017
Status: Terminated
Initiated by the company: Jun 22, 2017
Posted by the FDA: Jul 10, 2017
Recalling firm: Medtronic Perfusion Systems
Quantity: 63053 (48180 US) (14873 OUS)
Product code: DXS
FDA submissions: K852232
Distribution: 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.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

DLP® 62000
Medtronic, Inc. · GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
2 recalls0 reports
DLP® 61000
Medtronic, Inc. · GAUGE, PRESSURE, CORONARY, CARDIOPULMONARY BYPASS
1 recall0 reports

Product lines

DLPMedtronic, Inc. · 151 models · 592 reports · 32 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 77641).

Z-2764-2017 · Terminated
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Z-2765-2017 · Terminated
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer s…
Z-2766-2017 · Terminated
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in…
Z-2767-2017 · Terminated
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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