A leak the user cannot see — 15 device records turn on what is visible (Abiomed)
The U.S. FDA classified the "ABIOMED Introducer Kit 23 Fr, 11 cm" (pump set code 1000441) from Abiomed, Inc. as Class I — its most serious category — for potential sheath leakage. The record states plainly that the manufacturing issues are not visually detectable by the user, and distribution spans many countries including Japan.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmAbiomed, Inc.
- ReasonA potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
- DistributionWorldwide distribution. US Nationwide, Australia (AU), Austria (AT), Belgium (BE), Brazil (BR), Brunei (BN), Canada (CA), China (CN), Croatia (HR), Czech Republic (CZ), Denmark (DK), Finland (FI), Fr...
- Recall initiated2026-06-11
Key points
- Recall number Z-2684-2026; FDA Class I, the most serious category; status Ongoing.
- The product is the "ABIOMED Introducer Kit 23 Fr, 11 cm" (pump set code 1000441; introducer product code 2000342).
- The FDA record states the manufacturing issues are not visually detectable by the user — inspection at the point of use cannot catch them.
- A 14Fr or 23Fr introducer is provided in every pump set, so the issue reaches the basic build.
- Quantity 196 units; distribution worldwide including Japan. Voluntary, firm-initiated; initiated 2026-06-11, reported 2026-07-22.
- Of the 779 device records this site holds as of 2026-09-01, 15 mention visual inspection in the reason.
1The line that says users cannot see it
The heaviest sentence in this recall is one in the FDA record: these manufacturing issues are not visually detectable by the user. Device defects come in two kinds — those a clinician can catch when opening the package or inspecting before use, and those they cannot. The second kind cannot be stopped by care at the point of use.
That makes identifying affected lots from records and physically removing them the only remedy, so the effectiveness of the recall becomes the safety measure itself.
2A part that is in every pump set
The record adds a second important fact: a 14Fr or 23Fr introducer is provided in every pump set. This is not an option present in some configurations but part of the basic build. A manufacturing issue in one part therefore reaches every set containing it, which is why recalls citing the same reason appear under several different recall numbers.
3196 units, spread across many countries
The quantity is modest at 196 units, but distribution spans U.S. nationwide plus Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, the Netherlands, Norway, Panama and more. Circulatory support pumps are used in urgent situations, so even small numbers tend to be positioned in many countries.
4Fifteen device records turn on what is visible
Of the 779 device records this site holds as of 2026-09-01, 15 mention visual inspection in the reason for recall.
Most records set out the fault without saying whether it can be caught in the field. Records in which the firm itself writes that a user looking at the device cannot tell are few, and this is one. A fault that cannot be seen changes what is being asked, because care alone cannot make up for it.
Why it matters
When a defect is not visually detectable, incoming inspection and pre-use checks provide no line of defense, so safety rests entirely on the recall notice arriving and affected lots being identified. Hospitals should keep lot numbers and UDI in the device register and be able to query stock by product code. Emergency devices positioned in small numbers across many countries have different notification paths in each, so confirming the contact point at the local distributor is a practical preparation.
FAQ
Why does "not visually detectable" matter so much?
Was the product distributed to Japan?
Why is the quantity only 196 units?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2684-2026