Q’Apel Medical has announced the voluntary recall of 1,617 units of its 072 aspiration system including the Hippo catheter and Cheetah delivery tool—a recall categorised as Class I, the most serious type of medical device recall, by the US Food and Drug Administration (FDA).
Q’Apel first initiated a discontinuation and recall of these units on 26 February, with the US FDA Class I categorisation coming on 7 April, as detailed in a Q’Apel press release.
The recall was initiated after the company received a warning letter from the US FDA that “raised questions about whether the features and characteristics of the distal tip of the Hippo aspiration catheter were within the scope of its 510(k) clearance”, according to Q’Apel. The company’s recent release also notes that, “rather than pursue a new regulatory pathway, [Q’Apel] chose to voluntarily remove all affected product lots and discontinue the 072 aspiration system line as part of its strategic shift toward newer technologies”.
Q’Apel states that it has submitted three ‘medical device reportable’ adverse events for the Hippo product to date—including a reported tip detachment, retrieved without patient injury; a vessel rupture; and a vasospasm. The company further claims that, based on the company’s investigation of these events, factors other than the device’s distal tip likely contributed to the reported adverse events.
“Notably,” Q’Apel’s release continues, “each of these event types is a known risk associated with use of any aspiration catheter and is not unique to the Hippo product. The tip of any aspiration catheter used during a thrombectomy could potentially cause vasospasm and/or vascular injury.
“In particular, if the tip of an aspiration catheter triggers irritation of the vessel wall, it may manifest as vasospasm, which may be self-limiting or may require treatment (e.g. vasodilatation). Vascular injury may result in a non-flow limiting dissection that requires no intervention and causes no permanent morbidity; a flow-limiting dissection that requires intervention and may be associated with morbidity; or, in the extreme case, vessel perforation or rupture which requires intervention and likely results in morbidity or even mortality. If unretrieved, a detached tip of a catheter could result in serious adverse events, such as blockage of blood vessels, ischaemia of end organs, and death.”
The product was distributed in the USA, Qatar, United Arab Emirates, and the Republic of Kazakhstan.
Regarding actions to be taken by device users, Q’Apel notes that the relevant Hippo product configurations have been discontinued in all markets—and the company has proactively notified all customers and distributors, and will “continue to monitor the situation closely”. Consignees of the product should immediately return any available product inventory to the company and, if consignees have distributed the product to others, they should contact Q’Apel so that the company can notify them of this action and retrieve any remaining products, the release adds.
