Rocket R57405Recalls & reported problems

Rocket Medical PLC · Rocket KCH Fetal Bladder Catheter

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

Aug 1, 2019Terminated
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
Z-0512-2020 · Root cause: Labeling design · Recall details · FDA record ↗

Device details

UDI-DI	`05055270913678`
Brand	Rocket
Model	R57405
Company	Rocket Medical PLC
Product code	—
Class	—
FDA submission	H970001
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Closed-wound drainage kit, micro-drainage

A collection of sterile devices designed to drain small, superficial abscesses and/or fluid collections. It will typically include an introducer needle, a guidewire, and a flexible, single-lumen, micro-drainage catheter with attached dilator that allows for atraumatic over-the-wire placement of the catheter. The initial puncture is made with the needle, the guidewire is advanced through the needle, which is then removed, and the catheter/dilator is advanced over the guidewire to obtain access to the site. The kit may have a wide range of surgical applications (e.g., general and plastic surgery). This is a single-use device.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page