Device product

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

Z-1759-2025

April 17, 2025

Class I

Product summary

Firm: C.R. Bard Inc
Event: Event 96645
Status: Ongoing
Classification: Class I
Quantity: N/A
Official record key: device-enforcement:Z-1759-2025

Official wording

Reason: Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

Code information: All Lots within expiration/UDI: (01)00801741076848

Distribution pattern: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico OUS: Singapore, Canada, Belgium, Ireland, Netherlands, South Africa, Sweden, United Kingdom

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.