The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-3072-2017·Announced 2017-09-06

Medspira mcompass Balloon Catheters Recalled for Potential Separation

Medspira is recalling mcompass 2-channel Balloon Catheters because the balloon may separate from the inner stem and remain in the rectal cavity.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component separating and remaining in the patient's body (rectal cavity), which constitutes a significant injury risk and aligns with the 'Severe' criteria for structural defects or significant injury reports.

Plain-English summary

Medspira, LLC is recalling 355 units of mcompass 2-channel Balloon Catheters (Part # RMD-002-004, Lot Nos. 160627-10 and 160627-11). The recall includes 255 units distributed in the United States and 100 units distributed internationally.

The recall is due to a potential failure in the balloon bond within the inner catheter stem. This defect could cause the balloon to separate from the inner stem, leaving the balloon in the patient's rectal cavity. The mcompass Biofeedback Anorectal Manometry System is used for anorectal pressure studies, and the software component is not included in this recall.

The affected catheters were distributed to the states of California, Florida, Iowa, Idaho, and Texas, as well as to Austria, Italy, Malaysia, the Philippines, Sweden, and the United Kingdom. Users should stop using the affected catheters and contact Medspira for instructions on return or replacement.

The recalled product

Product
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate…
Manufacturer
Medspira, Llc
Category
Medical Device — Catheter
Hazard

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 (1)

  • Part # RMD-002-004 Lot No #'s 160627-10 and 160627-11.

Distribution

Distributed in 5 states:

Related recalls

Same hazard · component separation

See all →

Similar recalls