Z-0876-2015Class II

Bard Caliber (CL3030) Inflation Device

Name: Z-0876-2015 Bard Caliber (CL3030) Inflation Device
Creator: Perouse Medical
Published: 2014-10-06
License: https://open.fda.gov/license/

Perouse Medical / initiated 2014-10-06 / Terminated / root cause: design

FDA source

PEROUSE MEDICAL began a recall of Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the... on 2014-10-06. FDA classified it as Class II and gives the reason as "Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0876-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2014-12-29
Terminated: 2017-03-24
Recalling firm: Perouse Medical
Product: Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures
Product code: MAV Syringe, Balloon Inflation
Reason for recall: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Root cause tag: design
FDA root cause: Device Design
Action: Perouse Medical notified Distributors by Safety Alert Letter sent on October 06, 2014 and and October 07, 2014 by e-mail. The letter identified the defective products and lot numbers and provided a description of the malfunction, risk and mitigation statements. US distributors have been requested to provide the required information to their customers. In addition, the firm has updated device instructions for use. The firm is requiring its customer to fill out a safety notice acknowledgement of receipt form.
Quantity in commerce: 24821 units
Distribution: US Nationwide Distribution in the states of AZ and CO.
Product codes and lots: All lot numbers beginning with Numbers: 1403,1404,1405,1406,1407

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0876-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0876-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29
Z-0877-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-29

Product code MAV

K042449Class IIDolphin Inflation DeviceSedat S.A. / cleared 2005-04-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)