Capso Vision Recalls CapsoCAM Plus Capsule Endoscopy Systems
Capso Vision is recalling 1,882 CapsoCAM Plus capsule endoscopy systems because a defect in the capsule window may cause the housing to crack and leak during use.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (device failure and need for repeat exam) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Capso Vision, Inc. is recalling 1,882 units of the CapsoCAM Plus capsule endoscopy system (UDI: 00867770000209). The recall was initiated due to a defect in the capsule window that may be stressed during the production process and final packaging. This defect could cause the capsule housing to crack and leak when ingested by a patient.
If the capsule leaks, fluid from the patient may enter the device, potentially damaging internal components. This damage may prevent the retrieval of patient data, which could require the patient to repeat the endoscopic exam. The affected units were distributed in the United States (CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA) and in foreign countries including France, Argentina, Italy, the United Kingdom, Belgium, Turkey, Australia, Colombia, Gambia, Greece, Spain, Slovenia, Croatia, Morocco, and Sweden.
Healthcare providers and patients should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. If a unit is affected, it should be removed from service and returned to Capso Vision, Inc. according to the instructions provided by the manufacturer.
The recalled product
- Product
- CapsoCAM Plus, UDI: 00867770000209
- Manufacturer
- Capso Vision, Inc.
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 1,882
Distribution
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