AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Summary
The FDA issued a Class II for AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM by PROCEPT BIOROBOTICS CORPORATION. Reason: Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both t.
Details
Source
Device Recall
External ID
Z-2330-2021
Action Date
2021-09-01
Status
Ongoing
Category
device
Product Description
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Lot/Code Info: Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527
Quantity Affected: 608
Reason for Recall
Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-09
Company
Redwood City, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 155 device recalls issued in the same week, part of 403 device-related FDA actions this month.
PROCEPT BIOROBOTICS CORPORATION has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PROCEPT BIOROBOTICS CORPORATION) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PROCEPT BIOROBOTICS CORPORATION have FDA actions?
PROCEPT BIOROBOTICS CORPORATION has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2330-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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