Z-1869-2009

Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal...

Name: Z-1869-2009 Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal...
Creator: Maquet Cardiovascular
Published: 2009-05-19
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2009-05-19 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular began a recall of Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with... on 2009-05-19. The reason FDA records is "Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1869-2009
Status: Terminated
Initiated: 2009-05-19
Posted: 2009-08-31
Terminated: 2010-12-21
Recalling firm: Maquet Cardiovascular LLC
Product: Maquet Coronary Perfusion Cannulae with Balloon Tip, with either self-inflating balloon tip or cone distal tips, straight or right angle, available with proximal end fittings for either 1/4 inch connector or male luer fitting, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Undeclared allergen: Products are missing the warning label declaring that the products contain natural rubber latex.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Maquet Cardiovascular issued a notification letter to consignees on May 19, 2009.
Quantity in commerce: 2,226 devices
Distribution: Nationwide distribution.
Product codes and lots: Manufacturing lot numbers 272809 to 278615 and 70000241 to 70024294, Model numbers 210800, 210801, 210802, 210803, 210804, 210805, 210806, 210807, 210810, 210811, 210812, 210813, 210814, 210815, 210816, 210817, 215800, 215802, 215803, 215804, 215805, 215806, 215807, 215810, 215811, 215812, 215813, 215814, 215815, 215816, and 215817.

Product code DWF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)