CoolSculpting Control Unit BRZ-CG1-CUD-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2,595 adverse event reports that list this exact device (DI 00816417020001), received between Jan 16, 2019 and Sep 30, 2026 — classified as 1 death, 2,570 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (103 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 2,595 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50951600 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50949919 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported receiving CoolSculpting System treatment to the flanks and abdomen on (b)(6) 2026 with a CoolAdvantage Applicator and experiencing paradoxical hyperplasia in the flank areas.

  Patient problems: Hyperplasia

  MAUDE report 50937966 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that a patient was reading unverified social media accounts describing permanent nerve damage and pain after CoolSculpting treatment.

  Patient problems: Nerve Damage

  MAUDE report 50923725 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient experienced paradoxical hyperplasia and "rock hard mass" of the full abdomen, flanks and in the "right coastal area, in the area below umbilicus to the pubis" after CoolSculpting treatment on (b)(6) 2025 using an unknown applicator, 4 months post-treatment.

  Patient problems: Hyperplasia

  MAUDE report 50897627 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that patient experienced Paradoxical Hyperplasia to the back and anterior bra after CoolSculpting System treatment on (b)(6) 2025, using a Cool Advantage and Cool Advantage Plus applicators. 6-7 months post treatment.

  Patient problems: Hyperplasia

  MAUDE report 50896751 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50892551 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50876111 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50847625 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50828324 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that patient experienced "Paradoxical Hyperplasia and increase in the subcutaneous adipose tissue with firm consistency, with pain" to the flanks after CoolSculpting treatment on (b)(6) 2023 using an CoolAdvantage Applicator.

  Patient problems: Hyperplasia

  MAUDE report 50819829 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient experienced paradoxical hyperplasia of the bilateral inferior abdomen after CoolSculpting treatment on (b)(6) 2025 using a CoolAdvantage Applicator, 5 months post-treatment.

  Patient problems: Hyperplasia

  MAUDE report 50805012 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Sales representative reported on behalf of healthcare professional that a patient received an Unknown CoolSculpting System treatment with an unknown applicator and experienced Paradoxical Hyperplasia post treatment.

  Patient problems: Hyperplasia

  MAUDE report 50787475 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50781438 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient experienced paradoxical hyperplasia of the lower abdomen and the flanks after CoolSculpting treatment on (b)(6) 2025 using a CoolAdvantage Applicator, 10 months post-treatment.

  Patient problems: Hyperplasia

  MAUDE report 50776175 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  The patient reported enlargement in the flank area after treatment using an unknown CoolSculpting unit and an unknown applicator.

  Patient problems: Hyperplasia

  MAUDE report 50760769 ↗
• InjurySep 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperplasia

  MAUDE report 50741190 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare Professional reported "patient reporting increase firmness in area and increase sensitivity" after treatment with CoolSculpting System using a CoolAdvantage applicator to abdomen area, following treatments performed on (b)(6)2023 and (b)(6)2023. Healthcare Professional later reported "patient reports abdominal pain, bruising, swelling and some numbness."

  Patient problems: Hyperplasia

  MAUDE report 50571332 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient received CoolSculpting treatment over the abdomen, with a CoolAdvantage Plus Applicator for the CoolSculpting System. And presented pressure marks two days after treatment, then presented persistent erythema with mild scabbing and early post inflammatory hyperpigmentation (PIH) developing 12 days after treatment. Following treatment performed on (b)(6)2026, the patient was treated with mometasone for 5 days and followed by Fucicort for another 5 days. AbbVie Medical Safety determined first degree burn and Medical Device Reporting determined that the event is severe and needs to be reported.

  Patient problems: Cryogenic Burn

  MAUDE report 50420602 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient reported that they experienced paradoxical hyperplasia to the arms and abdomen after CoolSculpting treatments on (b)(6) 2021 and (b)(6) 2021, using an unknown applicator, 1 month after treatment. Patient described the following: "hardening" and "it is bulging". Patient received lymphatic massage.

  Patient problems: Hyperplasia

  MAUDE report 50419013 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported that a patient received a CoolSculpting System treatment on unknown area with an unknown applicator and experience Paradoxical Hyperplasia post treatment.

  Patient problems: Hyperplasia

  MAUDE report 50226318 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  A patient reported through social media post the experience of another patient after a CoolSculpting treatment that "In 2025, I had a video come up on my TikTok about Paradoxical Hyperplasia, and that is when it clicked what was happening". while using an unknown applicator for the unknown CoolSculpting System.

  Patient problems: Hyperplasia

  MAUDE report 50178527 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

  A healthcare professional reported that a patient received CoolSculpting treatment to an unknown area with an unknown applicator and was presented with Paradoxical Hyperplasia (PH) post treatment.

  Patient problems: Hyperplasia

  MAUDE report 50115447 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported through a Sales Representative a suspected case of Paradoxical Hyperplasia (PH), "texture change, fat has become much firmer and bulging" on lower abdomen and flanks area 76 months post treatment to submental, full abdomen and flanks areas with a CoolAdvantage applicator for a CoolSculpting System, following treatments performed on (b)(6) 2019 and (b)(6) 2020. Healthcare professional later reported patient experienced swelling and bruising on flanks area after first treatment.

  Patient problems: Hyperplasia

  MAUDE report 50101641 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Healthcare professional reported through a distributor that a patient experienced that their "abdomen is not deflating" (overall enlarged, like that of a pregnant woman) after CoolSculpting treatment in (b)(6) 2025 to the abdomen (upper and lower) using an unknown applicator. The healthcare professional also consulted about hyperplasia and later reported that "patient later indicated a wish to withdraw the case".Practice Development Manager later reported "In this case, when the clinic explained the characteristics of paradoxical hyperplasia symptoms to the patient, the patient withdrew their complaint and canceled the consultation."

  Patient problems: Hyperplasia

  MAUDE report 50036606 ↗