EsoFLIP 30mm Balloon Dilation Catheter Recalled for Measurement Inaccuracy
Covidien is recalling EsoFLIP 30mm balloon dilation catheters due to saline conductivity issues that may cause inaccurate esophageal measurements, potentially leading to patient harm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The saline conductivity issue creates a risk of inaccurate measurements that could harm patients, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Covidien, LLC is recalling the EsoFLIP 30mm Balloon Dilation Catheter (REF ES-330), a device used for esophageal dilation procedures.
The recalled devices may experience saline conductivity issues that could result in inaccurate esophageal diameter measurements during use. These inaccurate measurements could potentially lead to patient harm, although no injuries have been confirmed to date.
The affected lot numbers include: 22K0854JZ and 23H0552JZ (GTIN 10884521809451), and 22E0781JZ, 22E0997JZ, 22I0422JZ, 22I0424JZ, 22I0425JZ, 22J1362JZ, 22K0743JZ, 22K0744JZ, 22K0745JZ, 22K0746JZ, 22K0854JZ, 23A0109JZ, 23A0111JZ, 23A1200JZ, 23A1201JZ, 23A1202JZ, 23C0144JZ, 23C0668JZ, 23C0669JZ, 23D0777JZ, 23D0778JZ, 23H0047JZ, 23H0552JZ, 23H0553JZ, 23H0554JZ, 23H0623JZ, 23H0624JZ, 23L0331JZ, 23L0338JZ, 23L0339JZ, 24A0014JZ, 24A0015JZ, and 24B0392JZ (GTIN 20884521809458). The devices were distributed worldwide, including throughout the United States and to Argentina, Australia, Austria, Bahrain, Belgium, Canada, Denmark, Germany, Ireland, Italy, Kuwait, New Zealand, Norway, Portugal, Qatar, South Africa, Switzerland, and United Arab Emirates.
Healthcare providers should verify whether their facility has received any of the recalled lot numbers and consult with Covidien regarding appropriate corrective actions.
The recalled product
- Product
- EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only
- Manufacturer
- Covidien, LLC
- Category
- Medical Device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- GTIN Number: 10884521809451/ Lot: 22K0854JZ
- 23H0552JZ
- GTIN Number: 20884521809458/ Lot: 22E0781JZ
- 22E0997JZ
- 22I0422JZ
- 22I0424JZ
- 22I0425JZ
- 22J1362JZ
- 22K0743JZ
- 22K0744JZ
- 22K0745JZ
- 22K0746JZ
- 22K0854JZ
- 23A0109JZ
- 23A0111JZ
- 23A1200JZ
- 23A1201JZ
- 23A1202JZ
- 23C0144JZ
- 23C0668JZ
Distribution
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